MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETRIO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number ETRIO325H

Device Problems Break (1069); Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

It was reported that during a pelvic evisceration, the i-blade was broken when the device grasped the rectum tissue and the broken i-blade was missing.The tissue was thick and hard by radiation therapy.The broken i-blade was looked for in the patient's abdomen and the suction matter, but it was not found.Also, the patient was x-rayed, but the broken i-blade was not found.Another device was used to complete the case.There were no adverse consequences to the patient.One device will be returning.

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The device was received with the upper i-blade broken off not return and upper jaw separated and returned.The device was connected to the generator and it was recognized.Due to the condition of the i-blade and the jaw not all testing was performed with the generator.The condition of the i-blade and jaw prevented the functionality of the device.The jaw was unable to fully cycle open and close.As reported in the event description it is likely that the damage to the jaw and i-blade was caused by not allowing thick and fibrous tissues to denature prior to i-blade advancement or attempting to cut through thick dense tissue.

• Brand Name: ETRIO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3970464
• MDR Text Key: 4755292
• Report Number: 3005075853-2014-05365
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2015
• Device Catalogue Number: ETRIO325H
• Other Device ID Number: BATCH # K91210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR